Bristol-Myers Squibb Company BMY and Incyte Corporation INCY recently announced that the companies will advance their clinical development program. The clinical development program evaluates the combination of Incyte’s investigational oral selective IDO1 enzyme inhibitor epacadostat, with the former’s immuno-oncology therapy Opdivo into phase III studies.
The combination will be evaluated for the treatment of first-line non-small cell lung cancer across the spectrum of PD-L1 expression and first-line head and neck cancer.
Both the companies are expanding the ECHO-204 phase I/II study to include anti-PD-1/PD-L1 relapsed/refractory melanoma cohorts.
We remind investors that both the companies entered into a collaboration agreement in 2014. The trial will be funded by both the companies.
The program includes a broad range of clinical trials studying Opdivo, across all phases, including Phase III in a variety of tumor types. The program has enrolled more than 25,000 patients.
Bristol-Myers Squibb’s share price has decreased 18.1% in the last twelve months, while the Zacks classified Large Cap Pharmaceuticals industry gained 3.9%.
We remind investors that Opdivo is approved for varied indications in both the EU and the U.S. Opdivo has received approvals for several indications including melanoma, head and neck, lung, kidney and blood cancer. The Opdivo+Yervoy regimen is also approved in multiple markets for the treatment of melanoma.
The drug recorded sales of $3.4 billion in 2016, up from $942 million in 2014. Bristol-Myers is working on expanding the label of Opdivo further. Opdivo became the first PD-1 inhibitor to be approved for a hematological malignancy – classical Hodgkin lymphoma in both the U.S. (May 2016) and the EU (Nov 2016). In Nov 2016, Opdivo gained the FDA approval for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.
Label expansion into additional indications would give the product access to a higher patient population and increase the commercial potential of the drug.
Incyte has signed clinical trial collaboration agreements with Merck MRK and Roche RHHBY to evaluate epacadostat with their respective anti-PD-1 and anti-PD-L1 agents in phase I/II studies.
Bristol-Myers Squibb currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.
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